Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017)

This document gives guidance to cosmetic manufacturers and regulatory bodies to help define those
finished products that, based on a risk assessment, present a low risk of microbial contamination
during production and/or intended use, and therefore, do not require the application of microbiological
International Standards for cosmetics.

Kosmetische Mittel - Mikrobiologie - Leitlinien für die Risikobewertung und Identifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2017)

Dieses Dokument gibt Kosmetikherstellern und Aufsichtsbehörden, ausgehend von einer Risikobewertung, Hilfestellung bei der Festlegung derjenigen Fertigprodukte, die während der Herstellung und/oder der vorgesehenen Anwendung ein niedriges Risiko für eine mikrobielle Verunreinigung darstellen und demzufolge die Anwendung Internationaler Normen zur Mikrobiologie von kosmetischen Mitteln nicht erfordern.

Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et l'identification de produits à faible risque microbiologique (ISO 29621:2017)

ISO 29621:2017 donne des lignes directrices aux fabricants de cosmétiques et aux instances réglementaires afin de les aider à déterminer, en fonction d'une «appréciation du risque», les produits finis qui présentent un faible risque de contamination microbienne au cours de la fabrication et/ou de l'utilisation prévue, et, par conséquent, ne nécessitent pas la mise en ?uvre des Normes internationales de microbiologie relatives aux cosmétiques.

Kozmetika - Mikrobiologija - Smernice za oceno tveganja in prepoznavanja izdelkov, ki ne predstavljajo večjega mikrobiološkega tveganja (ISO 29621:2017)

Ta dokument podaja smernice za proizvajalce kozmetičnih izdelkov in regulativne organe za pomoč pri opredelitvi končnih izdelkov, ki na podlagi ocene tveganja predstavljajo nizko tveganje za mikrobiološko onesnaženje med proizvodnjo in/ali predvideno uporabo in zato ne zahtevajo uporabe mikrobioloških mednarodnih standardov za kozmetične izdelke.

General Information

Status
Published
Public Enquiry End Date
04-Jun-2016
Publication Date
08-Oct-2017
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
06-Sep-2017
Due Date
11-Nov-2017
Completion Date
09-Oct-2017

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SIST EN ISO 29621:2011
.R]PHWLND0LNURELRORJLMD6PHUQLFH]DRFHQRWYHJDQMDLQSUHSR]QDYDQMD
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Cosmetics - Microbiology - Guidelines for the risk assessment and identification of

microbiologically low-risk products (ISO 29621:2017)

Kosmetische Mittel - Mikrobiologie - Leitlinien für die Risikobewertung und Identifikation

von mikrobiologisch risikoarmen Produkten (ISO 29621:2017)

Cosmétiques - Microbiologie - Lignes directrices pour l'appréciation du risque et

l'identification de produits à faible risque microbiologique (ISO 29621:2017)
Ta slovenski standard je istoveten z: EN ISO 29621:2017
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
SIST EN ISO 29621:2017 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 29621:2017
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SIST EN ISO 29621:2017
EN ISO 29621
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 07.100.40 Supersedes EN ISO 29621:2011
English Version
Cosmetics - Microbiology - Guidelines for the risk
assessment and identification of microbiologically low-risk
products (ISO 29621:2017)

Cosmétiques - Microbiologie - Lignes directrices pour Kosmetische Mittel - Mikrobiologie - Leitlinien für die

l'appréciation du risque et l'identification de produits à Risikobewertung und Identifikation von

faible risque microbiologique (ISO 29621:2017) mikrobiologisch risikoarmen Produkten (ISO

29621:2017)
This European Standard was approved by CEN on 25 February 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 29621:2017 E

worldwide for CEN national Members.
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SIST EN ISO 29621:2017
EN ISO 29621:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 29621:2017
EN ISO 29621:2017 (E)
European foreword

This document (EN ISO 29621:2017) has been prepared by Technical Committee ISO/TC 217

"Cosmetics" in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of

which is held by AFNOR.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by September 2017, and conflicting national standards

shall be withdrawn at the latest by September 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.
This document supersedes EN ISO 29621:2011.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 29621:2017 has been approved by CEN as EN ISO 29621:2017 without any modification.

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SIST EN ISO 29621:2017
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SIST EN ISO 29621:2017
INTERNATIONAL ISO
STANDARD 29621
Second edition
2017-03
Cosmetics — Microbiology —
Guidelines for the risk assessment
and identification of microbiologically
low-risk products
Cosmétiques — Microbiologie — Lignes directrices pour
l’appréciation du risque et l’identification de produits à faible risque
microbiologique
Reference number
ISO 29621:2017(E)
ISO 2017
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SIST EN ISO 29621:2017
ISO 29621:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 29621:2017
ISO 29621:2017(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Risk assessment factors ................................................................................................................................................................................ 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Composition of the product ......................................................................................................................................................... 2

4.2.1 General characteristics ............................................................................................................................................... 2

4.2.2 Water activity, a , of formulation ...................................................................................................................... 2

4.2.3 pH of formulation ............................................................................................................................................................ 4

4.2.4 Raw materials that can create a hostile environment ..................................................................... 4

4.3 Production conditions ...................................................................................................................................................................... 6

4.4 Packaging ..................................................................................................................................................................................................... 6

4.5 Combined factors .................................................................................................................................................................................. 6

5 Identified low-risk products .................................................................................................................................................................... 7

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2017 – All rights reserved iii
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SIST EN ISO 29621:2017
ISO 29621:2017(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of ISO standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO’s adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by ISO/TC 217, Cosmetics.

This second edition cancels and replaces the first edition (ISO 29621:2010), which has been technically

revised.
iv © ISO 2017 – All rights reserved
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SIST EN ISO 29621:2017
ISO 29621:2017(E)
Introduction

Every cosmetic manufacturer has a dual responsibility relative to the microbiological quality of its

products. The first is to ensure that the product, as purchased, is free from the numbers and types of

microorganisms that could affect product quality and consumer health. The second is to ensure that

microorganisms introduced during normal product use will not adversely affect the quality or safety of

the product.

The first step would be to perform a microbiological risk assessment of the product to determine if the

cosmetic microbiological International Standards apply.

Microbiological risk assessment is based on a number of factors generally accepted as important in

evaluating the adverse effects on product quality and consumer health. It is intended as a guide in

determining what level of testing, if any, is necessary to assure the quality of the product. Conducting

a microbiological risk assessment involves professional judgment and/or a microbiological analysis, if

necessary, to determine the level of risk.

The nature and frequency of testing vary according to the product. The significance of microorganisms

in non-sterile cosmetic products is to be evaluated in terms of the use of the product, the nature of the

product and the potential harm to the user.

The degree of risk depends on the ability of a product to support the growth of microorganisms and

on the probability that those microorganisms can cause harm to the user. Many cosmetic products

provide optimum conditions for microbial growth, including water, nutrients, pH and other growth

factors. In addition, the ambient temperatures and relative humidity at which many cosmetic products

are manufactured, stored and used by consumers, will promote growth of mesophiles that could cause

harm to users or cause degradation of the product. For these types of products, the quality of the

finished goods is controlled by applying cosmetic good manufacturing practices (GMPs) (see ISO 22716)

during the manufacturing process, using preservatives and conducting control tests using appropriate

methods.

The likelihood of microbiological contamination for some cosmetic products is extremely low (or

non-existent) due to product characteristics that create a hostile environment for survival/growth of

microorganisms. These characteristics are elaborated in this document. While the hazard (adverse

effects on product quality and consumer health) may remain the same for these products, the likelihood

of an occurrence is extremely low. These products identified as “hostile” and produced in compliance

with GMPs pose a very low overall risk to the user.

Therefore, products that comply with the characteristics outlined in this document do not require

microbiological testing.

This document gives guidance to cosmetic manufacturers and regulatory bodies to determine when,

based on a “risk assessment,” the application of the microbiological International Standards for

cosmetics and other relevant methods is not necessary.
© ISO 2017 – All rights reserved v
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SIST EN ISO 29621:2017
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SIST EN ISO 29621:2017
INTERNATIONAL STANDARD ISO 29621:2017(E)
Cosmetics — Microbiology — Guidelines for the risk
assessment and identification of microbiologically low-risk
products
1 Scope

This document gives guidance to cosmetic manufacturers and regulatory bodies to help define those

finished products that, based on a risk assessment, present a low risk of microbial contamination

during production and/or intended use, and therefore, do not require the application of microbiological

International Standards for cosmetics.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
risk
effect of uncertainty on objectives

Note 1 to entry: Microbiological risk is associated with the ability of a product to

— support the growth of microorganisms and the probability that those microorganisms can cause harm to

the user;

— support the presence of specified microorganisms as identified in cosmetic microbiological International

Standards, e.g. ISO 18415, ISO 18416, ISO 22717, ISO 22718 and ISO 21150.
[SOURCE: ISO Guide 73:2009, 1.1, modified]
3.2
risk assessment

overall process of risk identification, risk analysis (3.3) and risk evaluation (3.4)

[SOURCE: ISO Guide 73:2009, 3.4.1]
3.3
risk analysis

process to comprehend the nature of risk (3.1) and to determine the level of risk

[SOURCE: ISO Guide 73:2009, 3.6.1]
© ISO 2017 – All rights reserved 1
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SIST EN ISO 29621:2017
ISO 29621:2017(E)
3.4
risk evaluation

process of comparing the results of risk analysis (3.3) with risk criteria (3.5) to determine whether the

risk (3.1) and/or its magnitude is acceptable or tolerable
[SOURCE: ISO Guide 73:2009, 3.7.1]
3.5
risk criteria
term of reference against which the significance of a risk (3.1) is evaluated
[SOURCE: ISO Guide 73:2009, 3.3.1.3, modified]
3.6
microbiologically low-risk product

product whose environment denies microorganisms the physical and chemical requirements for

growth and/or survival

Note 1 to entry: This category of low-risk products applies to microbiological contamination which may occur

during manufacturing and/or intended use by the consumer.

Note 2 to entry: A product whose packaging prevents the ingress of microorganisms is considered a

microbiological low-risk product during its use.

Note 3 to entry: The inclusion of preservatives or other antimicrobial compounds in a formulation by itself would

not necessarily constitute a low-risk product.
4 Risk assessment factors
4.1 General

A number of product characteristics needs to be evaluated when performing a microbial risk assessment

to determine if that product should be subjected to the published microbiological International

Standards for cosmetics or other relevant methods. These characteristics include the composition of

the product, the production conditions, packaging and a combination of these factors.

4.2 Composition of the product
4.2.1 General characteristics

Products with certain physico-chemical characteristics do not allow the proliferation of microorganisms

of concern to cosmetic products. Any number of physico-chemical factors or combinations thereof in

a product can create a hostile environment that will not support microbial growth and/or survival.

Combinations of sub-lethal factors will increase the hostility of the environment and increase the lag

phase. If the environment is hostile enough, the lag phase will be extended to infinity and therefore

cause cell death. Combinations of lethal factors will cause rapid cell death. The following factors should

be considered in determining whether cosmetic products present a hostile environment.

4.2.2 Water activity, a , of formulation

Water is one of the most important factors controlling the rate of growth of an organism. It is not

the total moisture content that determines the potential for growth but the available water in the

formulation. The metabolism and reproduction of microorganisms require the presence of water in an

available form. The most useful measurement of water availability in a product formulation is water

2 © ISO 2017 – All rights reserved
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SIST EN ISO 29621:2017
ISO 29621:2017(E)

activity, a . Water activity is defined as the ratio of the water vapour pressure of the product to that of

pure water at the same temperature [see Formula (1)]:
a == (1)
nn+
0 ()
where
p is the vapour pressure of the solution;
p is the vapour pressure of pure water;
n is the number of moles of solute;
n is the number of moles of water.

When a solution becomes more concentrated, vapour pressure decreases, and the water activity falls

from a maximum of 1,00 (a for pure water). These conditions have been categorized with respect to

their capacity to grow and produce metabolites in various conditions and values of a . The influence

of reduced a on microorganisms is well documented. As the amount of free water in a formulation

is reduced (decrease in a ), the microorganism is faced with the challenge of maintaining a state of

turgor within the cell. Loss of turgor will result in slower growth and eventually death of the cell. Many

organisms survive under conditions of low a but will not grow. Lowered a causes an increase in the

w w

lag phase of growth, decrease in growth and decrease in total cell count. At very low values of a , it can

be assumed that the lag phase becomes infinite, i.e. no growth. In low a environments, cells shall use

energy to accumulate compatible solutes to maintain internal pressure. The growth of most bacteria is

confined to an a above 0,90. Some yeast and mould can grow at a much lower a with a limiting value

w w
above 0, 60 (see References [1] and [2]).

Listed in Table 1 are examples of the minimum water activity levels required for growth of selected

microorganisms.

Table 1 — Approximate minimum water activity (a ) required for growth of selected

microorganisms
Water activity Water activity
Bacteria Molds and yeast
(a ) (a )
w w
Pseudomonas aeruginosa 0,97 Rhizopus nigricans 0,93
Bacillus cereus 0,95 Mucor plumbeus 0,92
Clostridium botulinum, Rhodotorula mucilaginosa
0,95 0,92
Type A
Escherichia coli 0,95 Saccharomyces cerevisiae 0,90
Clostridium perfringens 0,95 Paecilomyces variotii 0,84
Lactobacillus viridescens 0,95 Penicillium chrysogenum 0,83
Salmonella spp. 0,95 Aspergillus fumigatus 0,82
Enterobacter aerogenes 0,94 Penicillium glabrum 0,81
Bacillus subtilis 0,90 Aspergillus flavus 0,78
Micrococcus lysodeikticus 0,93 Aspergillus brasiliensis 0,77
Staphylococcus aureus Zygosaccharomyces rouxii
0,86 0,62
(see Reference [2]) (osmophilic yeast)
Halobacterium halobium Xeromyces bisporus
0,75 0,61
(halophilic bacterium) (xerophilic fungi)

The water activity values in Table 1 should be considered as reference points, since microbial

growth may occur at lower values depending on differences in temperature, pH or nutrient content

of the product formulation. Even though water activity values are important in assisting in the

© ISO 2017 – All rights reserved 3
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SIST EN ISO 29621:2017
ISO 29621:2017(E)

risk analysis for microbial contamination, water activity should not be used as the sole indicator in

determining whether product testing is necessary for a particular product formulation. USP indicates

that pharmaceutical products with water activities below 0,75 prevent microbial growth. Generally,

anhydrous product formulations will have low water activity levels (e.g. <0,7) (see References [3],

[4] and [5]). A water activity level greater than 0,8 is required for microorganisms to proliferate in

a product formulation (see References [6] and [7]). Because the possibility of microbial proliferation

is non-existent in product formulations that have a water activity level lower than 0,7, there is no

need to conduct preservative challenge testing in these types of product formulations. In the absence

of chemical preservatives, a low water activity level alone is more than sufficient to keep a product

adequately preserved (see Reference [8]). Similar values may apply to cosmetics. Other factors, such as

manufacturing and filling temperatures, should be taken into consideration to determine if a product

requires further microbiological testing.
4.2.3 pH of formulation

The use of acidic pH is a common practice in the food industry for protection against bacteria and these

same principles apply to cosmetics. The combination of acidic pH and a has been thoroughly studied

(see Reference [9]). In many instances, the level of inhibition on microbial activity depends on the

specific acid being used. Acidic conditions around pH 5 favour mould and yeast proliferation but will

not support bacterial growth. As the pH falls below pH 3,0, the conditions for growth of yeast become

hostile (see Reference [10]); this is because intracellular pH has to be maintained within relatively

narrow limits.

Alkaline pH may also create a hostile environment and may in some products be used as part of

their preservative system. Liquid soaps with alkaline pH (pH 9,0 to pH 10,0) present an environment

unfavourable for the growth of some microorganisms (see Reference [11]). Hair curl relaxers, due to

their extreme pH (around 12), prevent the growth of virtually all microorganisms that would be likely

to contaminate cosmetic products (see Reference [12]).

The reason for this is that the extreme pH, either acidic or alkaline, makes it necessary for

microorganisms to expend energy on maintenance of intracellular pH rather than growth. When pH

is used in combination with chelating agents, glycols, antioxidants, water activity and high surfactant

levels, an environment can be created which will not support microbial growth.

These concepts may be visualized as “hurdles” that microorganisms shall overcome in order to grow

(see Reference [13]).

In certain product types, where extreme pH levels are reported, those considered pH ≤3,0 and pH ≥10,0

do not require microbiological testing, including both challenge-test and end product testing. At all

other pH values (>3,0 but <10,0), a combination of pH and other physico-chemical factors needs to be

evaluated to determine potential risk. Data to support the conclusion that the microbiological risk is

low may need to be generated, either through experimental design or review of product history.

4.2.4 Raw materials that can create a hostile environment
4.2.4.1 Alcohol

Microbial growth is prevented in aqueous systems containing >20 % by volume mass of absolute ethyl

alcohol. However, lower alcohol levels (5 % to 10 %) may have additive or synergistic activity when

combined with other physico-chemical factors (see Reference [14]).

Ethanol, n-propanol and iso-propanol are the most frequently used aliphatic alcohols in cosmetic

preparations (see Reference [15]). Their antimicrobial efficacy increases with molecular weight and

chain length. The concentration in which they are present in a product determines whether they will

kill or merely inhibit microorganisms. Data in the literature indicate that the microbiostatic effect

of alcohol is quite high in the range of 10 % to 20 %, and will allow for a reduction in preservation.

Depending on the pH of the substrate, 15 % to 18 % ethyl alcohol has generally been considered

acceptable for preservation (see Reference [16]).
4 © ISO 2017 – All rights reserved
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SIST EN ISO 29621:2017
ISO 29621:2017(E)

Products containing alcohol levels ≥20 % by volume mass do not require microbiological testing

(challenge-test and end product testing). At levels below 20 %, other physico-chemical factors need to

be evaluated to determine potential risk. Data to support the conclusion that the microbiological risk is

low may need to be generated, either through experimental design or review of product history.

4.2.4.2 Ammonia and monoethanolamine

Ammonia and monoethanolamine, two alkaline agents, are commonly used in hair dyes where they

serve three important purposes: i) swell the hair fibre to allow dye precursors to better penetrate, ii)

generate the active peroxide species necessary for melanin bleaching and dye formation, iii) participate

[12]

to the bleaching of melanin. They are also used in waving lotions, which involve the reduction of

the structural disulphide bonds of the hair. They facilitate the penetration of waving lotion, which is

usually alkaline and is applied to the hair once it is set in rollers. Besides these primary functions, as

alkalizers, ammonia and monoethanolamine are expected to create a hostile environment for microbial

growth in the products in which they are used (see References [17] and [18]).

Products containing ammonia level ≥0,5 % and/or monoethanolamine level ≥1 % deny microorganisms

the physical and chemical requirements for growth and/or survival, and can therefore be considered as

microbiologically low-risk (see Reference [15]).
4.2.4.3 Polar organic solvents (e.g. ethyl acetate and butyl acetate)

Butyl acetate and ethyl acetate are organic solvents commonly used in nail polishes. These are basically

made from nitrocellulose dissolved in solvents. Solvents are liquids used to mix the other ingredients

(film formers, resins, plasticizers, pigments, etc.) in a nail polish to yield a uniformly spread product.

Besides this primary function, these organic solvents, when used at concentration >10 %, create a

hostile environment for microbial growth in the formulae in which they are used (see Table 2).

Mixtures of these solvents, which are characteristic of nail varnish compositions, have a high

microbiocidal activity on the tested strains within a short time (see Reference [19]).

Solvent-based nail polishes can therefore be considered low microbiological risk and do not require

microbiological testing (challenge-test and end product testing).
4.2.4.4 Other raw materials that can create a hostile environment
The use of certain raw m
...

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